Home › SYNOVIS MICRO COMPANIES ALLIANCE, INC › GEM FLOW COUPLER
GEM FLOW COUPLER
SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM2754 FC · UDI-DI 00844735006018
9
510(k) clearances
601
Adverse events
6
Recalls
4
Facilities
Description
The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FlowCOUPLER rings, and an external lead. The FlowCOUPLER rings are made of high density polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and probe which allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-28 | Baxter Healthcare Corporation | Potential for the battery to lose its ability to be recharged. |
| 2020-06-02 | Baxter Healthcare Corporation | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. |
| 2020-03-05 | Baxter Healthcare Corporation | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-03-05 | Baxter Healthcare Corporation | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-03-05 | Baxter Healthcare Corporation | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2008-05-14 | Synovis Micro Companies Alliance Inc | Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.